Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients

In this study, the investigators aimed to observe the effects of medium cut-off dialysis filters and high-flux dialysis filters on malnutrition inflammation score, uremic itching, restless leg syndrome, anemia, and ESA treatment, which are prominent complications in hemodialysis, and routine follow-up parameters.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Restless Legs Syndrome; Anemia of Chronic Kidney Disease; Hemodialysis-Associated Pruritus; Malnutrition-Inflammation-Cachexia Syndrome
• Intervention / Treatment: Device: Dialysis using the Theranova-400 device.; Device: Dialysis using the FX80 device.

Detailed Description

The study is designed as a single-center, prospective, observational research. A total of 50 stable-course chronic hemodialysis patients over 18 years of age and treated for at least 3 months will be included in the study and the study period will be planned for 12 months. 25 of the 50 chronic hemodialysis patients planned to be included in the study will use MCO-membrane and the other 25 will use high-flux membrane. The distribution of patients to the high-flux membrane and MCO membrane groups will be done randomly (sequentially single-pair number method). Then, the standard 12-hour (3x4 hours/week) hemodialysis treatment will continue. At the beginning of the study (0.), at the end of the third (3.) month and at the end of the sixth (6.) month;

Monthly laboratory tests routinely performed on hemodialysis patients (tests routinely performed in hemodialysis patient follow-up) 5 ml blood samples will be taken from the hemodialysis set to determine the levels of medium-large molecule-weight toxins-wastes and inflammatory parameters before and after dialysis, and the sera will be separated and stored at -80oC for use at the end of the study.

Automatic blood pressure measurement will be performed before and after hemodialysis to evaluate arterial stiffness.

The Malnutrition Inflammation Score will be applied to evaluate the nutritional status (the MIS form is given in the appendix) Visual Analog Scale will be used for appetite Visual Analog Scale will be used for uremic pruritus Depression scale screening (Beck's scale)

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Turkey
  • Karaköprü
    • Şanlıurfa, Karaköprü, Turkey, 63000
      • Mehmet Akif Inan Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Prevalent patients who are receiving hemodialysis treatment three times a week and are otherwise in stable condition.

Description

Inclusion Criteria:

• Chronic hemodialysis patients
• Patients continuing the hemodialysis program for at least 3 months
• Patients over 18 years of age

Exclusion Criteria:

• Patients with advanced heart failure, malignancy, terminal illness
• Patients with active infectious disease
• Acute hemodialysis patients
• Patients vascular access dysfunction

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The Theranova 400 group, also known as the MCO group.; Patients undergoing maintenance hemodialysis will receive dialysis treatment using the Theranova 400 device.	Device: Dialysis using the Theranova-400 device.; Patients receive hemodialysis treatment using the Theranova-400 dialyzer.
The FX80 group, also known as the high-flux group.; Patients undergoing maintenance hemodialysis will receive dialysis treatment using the FX80 device.	Device: Dialysis using the FX80 device.; Patients receive hemodialysis treatment using the FX80 dialyzer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malnutrition-inflammation score (MIS)	At the start of the study, the malnutrition-inflammation score will be recorded. This score ranges from 0 to 30, with higher scores indicating worse outcomes.	Prior to randomization, at the start of the study.
Malnutrition-inflammation score (MIS)	The malnutrition-inflammation score will be recorded at the conclusion of the study. This score ranges from 0 to 30, with higher scores indicating worse outcomes.	At the end of the 6th month after randomization.
Depressive disorder	At the start of the study, the Beck's depression scale will be recorded. This score ranges from 0 to 63, with higher scores indicating worse depression.	Prior to randomization, at the start of the study.
Depressive disorder	At the conclusion of the study, the Beck's depression scale will be recorded. This score ranges from 0 to 63, with higher scores indicating worse depression.	At the end of the 6th month after randomization.
Uremic pruritus	At the start of the study, the visual analog scale for pruritus will be recorded. This score ranges from 0 to 10, with higher scores indicating worse itching.	Prior to randomization, at the start of the study.
Uremic pruritus	At the conclusion of the study, the visual analog scale for pruritus will be recorded. This score ranges from 0 to 10, with higher scores indicating worse itching.	At the end of the 6th month after randomization.
Restless leg syndrome	At the start of the study, the Restless Leg Syndrome screening questionnaire will be administered. This score ranges from 0 to 40, with higher scores indicating worse symptoms.	Prior to randomization, at the start of the study.
Restless leg syndrome	At the conclusion of the study, the Restless Leg Syndrome screening questionnaire will be administered. This score ranges from 0 to 40, with higher scores indicating worse symptoms.	At the end of the 6th month after randomization.
Appetite	At the start of the study, the visual analog scale of appetite will be recorded. This score ranges from 0 to 5, with higher scores indicating better appetite.	Prior to randomization, at the start of the study.
Appetite	At the conclusion of the study, the visual analog scale of appetite will be recorded. This score ranges from 0 to 5, with higher scores indicating better appetite.	At the end of the 6th month after randomization.
Hemoglobin	Hemoglobin levels will be measured on a monthly basis.	March 2020
Hemoglobin	Hemoglobin levels will be measured on a monthly basis.	April 2020
Hemoglobin	Hemoglobin levels will be measured on a monthly basis.	May 2020
Hemoglobin	Hemoglobin levels will be measured on a monthly basis.	June 2020
Hemoglobin	Hemoglobin levels will be measured on a monthly basis.	July 2020
Hemoglobin	Hemoglobin levels will be measured on a monthly basis.	August 2020
Hemoglobin	Hemoglobin levels will be measured on a monthly basis.	September 2020
Erythropoietin Doses	Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.	March 2020
Erythropoietin Doses	Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.	April 2020
Erythropoietin Doses	Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.	May 2020
Erythropoietin Doses	Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.	June 2020
Erythropoietin Doses	Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.	July 2020
Erythropoietin Doses	Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.	August 2020
Erythropoietin Doses	Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.	September 2020
Phosphorus levels control	Serum phosphorus levels will be tested on a monthly basis.	March 2020
Phosphorus levels control	Serum phosphorus levels will be tested on a monthly basis.	April 2020
Phosphorus levels control	Serum phosphorus levels will be tested on a monthly basis.	May 2020
Phosphorus levels control	Serum phosphorus levels will be tested on a monthly basis.	June 2020
Phosphorus levels control	Serum phosphorus levels will be tested on a monthly basis.	July 2020
Phosphorus levels control	Serum phosphorus levels will be tested on a monthly basis.	August 2020
Phosphorus levels control	Serum phosphorus levels will be tested on a monthly basis.	September 2020
Parathyroid hormone levels control	Serum parathyroid hormone levels will be tested on a monthly basis.	March 2020
Parathyroid hormone levels control	Serum parathyroid hormone levels will be tested on a monthly basis.	April 2020
Parathyroid hormone levels control	Serum parathyroid hormone levels will be tested on a monthly basis.	May 2020
Parathyroid hormone levels control	Serum parathyroid hormone levels will be tested on a monthly basis.	June 2020
Parathyroid hormone levels control	Serum parathyroid hormone levels will be tested on a monthly basis.	July 2020
Parathyroid hormone levels control	Serum parathyroid hormone levels will be tested on a monthly basis.	August 2020
Parathyroid hormone levels control	Serum parathyroid hormone levels will be tested on a monthly basis.	September 2020

Collaborators and Investigators

• Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
• Investigators: Principal Investigator: Tuncay Sahutoglu, M.D., Mehmet Akif Inan Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Skin Diseases; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Urologic Diseases; Disease Attributes; Disease; Renal Insufficiency; Nutrition Disorders; Body Weight; Parasomnias; Body Weight Changes; Skin Manifestations; Weight Loss; Chronic Disease; Thinness; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Depressive Disorder; Syndrome; Kidney Diseases; Renal Insufficiency, Chronic; Inflammation; Restless Legs Syndrome; Malnutrition; Pruritus; Cachexia
• Other Study ID Numbers: MCOx_MAIEAH_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No